Thrombotic disorders are characterized by formation of a thrombus that obstructs vascular blood flow locally or detaches and embolizes to occlude blood flow downstream. Thrombotic disorders are a major cause of death in the industrialized world. Antiplatelet drugs, which decrease platelet aggregation and inhibit thrombus formation, have been shown to be beneficial in the treatment and prevention of thrombotic disorders.
Presently there are numerous antiplatelet drugs which are widely available, however, most antiplatelet drugs are associated with side effects. For example, the administration of antiplatelet agents, such as aspirin and clopidogrel, have been associated with gastrointestinal disorders such as ulcers and gastrointestinal bleeding. In addition, the administration of antiplatelet agents, such as clopidogrel, may make some patients more susceptible to the ulcerogenic effects of ulcerogenic stimuli. It appears that a major factor contributing to the development of these gastrointestinal disorders is the presence of acid in the stomach and upper small intestine. While the mechanisms associated with ulcers and gastrointestinal bleeding are not entirely known, there are many causes of ulcers, including stress, alcohol irritation, Helicobacter pylori infection, and the side effects of non-steroid anti-inflammatory drugs such as aspirin, for example. Patients in need of long term antiplatelet drug therapy often may interrupt or not receive such therapy due to gastrointestinal disorders, and as a result, patients are deprived of beneficial antiplatelet drug therapy. There is a need for oral pharmaceutical combination formulations to reduce or eliminate the gastrointestinal disorders associated with use of antiplatelet drugs.